2023-506138-65-00CompletedPhase 4
Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 May 2025
Brief summary (registry, in English)
Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 468 (actual)
- First submitted
- 4 Sept 2023
- Start date
- 20 Feb 2025
- Lead sponsor
- Medical University Of Gdansk
- Diseases
- Heart failure
- EU CT number
- 2023-506138-65-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 468
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- Current treatment in another clinical trial. 2. Hypersensitivity to trimetazidine. 3. Symptoms of parkinsonism. 4. Unavailability for all visits. 5. ≥3 class in CCS scale 6. Revascularization or venous thromboembolism within 3 months prior to the screening visit. 7. Hemodynamically significant valvular disease, hypertrophic cardiomyopathy, myocarditis and pericarditis, congenital heart disease, cardiac amyloidosis. 8. Severe ventricular arrhythmias. 9. Uncontrolled BP: SBP >170 or <85 mmHg or DBP >100 mmHg at screening or randomization visit; 10. Resting heart rate (HR) >110/min or <50/min; 11. Chronic kidney disease with eGFR <30 mL/min. 12. Blood total bilirubin ≥2 times the upper limit of normal (ULN) or ALAT or AST ≥3 times the (ULN). 13. Patient life expectancy <2 years. 14. Diagnosed malignant neoplasm within 5 years prior to screening or active cancer disease. 15. Organ transplant recipient. 16. Alcoholism. 17. Active infection as assessed by the investigator 18. Severe dysfunction of the musculoskeletal system. 19. Blood concentration of TSH or fT4 exceeding by 50% the upper and/or lower limit of the reference range. 20. Taking any drugs related to the treatment of Parkinson's disease, i.e. levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine within three months before screening. 21. A woman trying to get pregnant naturally or in vitro, or a woman who is menstruating unwilling to protect herself against unplanned pregnancy.
Who the study is looking for
- Expressing willingness to participate in the study and after obtaining information about the study, signing the informed consent form for participation in the clinical study. 2. Age at study entry ≥55 years and ≤85 years; 3. NYHA Class I to III at last screening assessment. 4. Documented diagnosis of HFpEF or new diagnosis of HFpEF based on HFA-PEFF score ≥ 5 by a cardiologist during the screening phase. 5. LVEF ≥ 50% on echocardiographic screening. 6. No modification of pharmacotherapy for at least 3 months prior to screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy | Bydgoszcz | Poland | Completed |
| KARDIOLAB Poradnia Kardiologiczna | Elbląg | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Completed |
| Copernicus Podmiot Leczniczy Sp. z o.o | Gdansk | Poland | Completed |
| Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej | Gdynia | Poland | Completed |
| NZOZ Centrum Medyczne Dąbrowa-Dąbrówka | Gdynia | Poland | Completed |
| Salve Medica Sp. z o.o. S.K. | Lodz | Poland | Completed |
| Specjalistyczna Praktyka Lekarska — "NEFRON" Beata Januszko-Giergielewicz | Olsztyn | Poland | Completed |
| Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o. | Słupsk | Poland | Completed |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher | Warsaw | Poland | Completed |
| Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji | Warszawa | Poland | Completed |
| Praktyka Lekarska - Tomasz Borkowski | Włocławek | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.